Human Repeat Insult Patch Test to Evaluate Skin Irritation and Sensitization in Healthy Volunteers

Part of paid clinical trials in Monroeville, Pennsylvania.

Sponsor
SerenaGroup, Inc.
Study ID
NCT07473661
Status
Completed

Conditions

  • Healthy Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Collagen-Based Material — DEVICE
    A collagen-based material applied under occlusive patch conditions to assess skin irritation and sensitization in healthy adult participants.

Study Details

This study evaluates skin irritation and sensitization following repeated application of a collagen-based material in healthy adult volunteers under controlled conditions. Skin responses will be assessed during study participation.

Key Dates

Start date
Feb 27, 2026
Status verified
May 2026
Primary completion
May 8, 2026
Completion
May 8, 2026

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Human Repeat Insult Patch Test Procedure
    Participants will undergo repeated occlusive patch applications of a collagen-based material to assess skin irritation and sensitization in healthy adult volunteers.

Primary Outcome Measure

Dermal Irritation Score Using the International Contact Dermatitis Research Group (ICDRG) Scale [ Time Frame: During the induction phase (approximately 3 consecutive weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
SerenaGroup MonroevilleMonroevillePennsylvania15146-

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SerenaGroup Monroeville· Monroeville, PA

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